What You Should Know about Direct-to-Consumer Advertising of Prescription Drugs.

• Author: Dukes, David E.

While there is an assault on the applicability of the learned intermediary doctrine in DTC cases, defense counsel can employ positive positions

"Let no physician teach the people about medicines or even tell them the names of the medicines, particularly the more potent ones. ... For the people may be harmed by their improper use."--Royal College of Physicians, circa 1550.

DIRECT marketing of pharmaceutical and biological products to consumers has come a long way since the 16th century, but it is still a relatively new phenomenon. For manufacturers and distributors, direct-to-consumer (DTC) advertising requires a careful balancing of risks and benefits, much like the decision that must be made by a patient and physician in prescribing medication. The potential benefits run not only to the pharmaceutical company in terms of market share and revenue, but also to the consumer who potentially benefits from, among other things, awareness of new treatment modalities and occasionally from a heightened awareness of an undiagnosed condition.

However, as with prescription drugs themselves, there are potential side effects to direct promotion of prescription products. The manufacturer or distributor who chooses to advertise a product directly to consumers must navigate through U.S. Federal Drug Administration regulations to ensure that the product's advertisements are true and not misleading in all respects, while fairly balancing information concerning risks and effectiveness. DTC advertising also carries liability risks, as the plaintiffs' bar has made some footholds in convincing courts to abandon the learned intermediary doctrine.

Proponents and opponents of direct-to-consumer advertising have established their rhetoric and staked out their positions. Proponents generally point out that DTC advertising raises public awareness of new treatments and reaches segments of the population--for example, rural physicians--that might not otherwise be aware of a new drug's availability. Greater awareness may lead patients to begin or resume treatment for conditions after old treatment modalities have been abandoned or avoided. Pharmaceutical advertisements also may alert consumers to previously undiagnosed diseases. Ultimately, a better-informed patient is better equipped to make informed healthcare choices.

Detractors of pharmaceutical advertising contend that consumer-directed marketing alters the physician-patient relationship by forcing physicians to succumb to patient pressure in making prescribing decisions.

It is argued that advertising leads consumers to seek medications they do not need, or to forgo more appropriate, less expensive and safer treatment options. DTC advertising, the opponents contend, promotes consumer self-diagnosis to the point that patients are pitted against their physicians, leading patients to doctor-shop for willing prescribers. On a slippery slope, it then is argued, physicians will face an economic incentive to relax their prescribing criteria in an effort to retain patients.

Opponents further suggest that in an age of managed care, physicians spend less time with their patients, consequently leaving inadequate time for the physician to convey adequate warnings about a prescription product to the patient, so that the patient can make an informed choice about whether to use the drug. Essentially, the opponents of pharmaceutical advertising believe that advertising produces a fundamental change in the physician-patient relationship that relegates the physician to the role of a script-writing automaton.

Finally, DTC detractors note that most pharmaceutical products promoted to consumers are "lifestyle" drugs and that drugs for more complex conditions and diseases receive less promotion.

For the pharmaceutical company engaging in direct-to-consumer advertising, these are the types of arguments that will be advanced by plaintiffs' attorneys seeking abolition of the learned intermediary doctrine. A minority of decisions has declined to follow this essential and well-reasoned defense. For pharmaceutical companies promoting their products directly to consumers, and for the attorneys who represent them, an understanding of the applicable statutes, regulations and decisions affecting these issues is essential.(1)

A LITTLE HISTORY

In 1963, the FDA proposed the first regulation of drug advertising. In the 1970s, the U.S. Supreme Court acknowledged that First Amendment freedom of speech protections are available to commercial speech in the context of price advertisements for prescription drugs.(2) In 1983, the FDA requested a voluntary moratorium on DTC advertising on account of a lack of policy concerning such advertisement, but by 1985 it lifted the ban. However, consumer-directed advertisements were made subject to the same standards as pharmaceutical promotion to physicians. Regulations at that time required "fair balance" and "full disclosure," as well as a "brief summary" of side effects, contraindications and effectiveness; essentially, the product's entire approved label.

Pharmaceutical advertisements began appearing in newspapers and magazines. Because the statutes and regulations then required that all advertisements include a full version of the approved product label, broadcast advertising was cost prohibitive in most instances. Advertisers could avoid this burdensome requirement by not identifying their product's particular use in the advertisement.

By 1997, the FDA issued a draft guidance for consumer-directed broadcast advertisements that permitted those advertisements to include the product's purpose. By the time the FDA issued the final guidance in 1999, pharmaceutical advertisements were appearing and being broadcast routinely on television, radio, billboards, in newspapers, magazines, and on the Internet.(3)

STATUTES, REGULATION, GUIDANCE

1. Statutes

   The Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. [sections] 352(n), does not define "advertising," but it is clear from the regulations that "advertising" includes broadcast and print promotion. Advertising is distinct from labeling, which is defined at 21 U.S.C. [sections] 321(k), (m). In the Internet age, however, it is not as clear whether Internet promotion is "advertising" or more akin to "labeling."(4)

   21 U.S.C. [sections] 331 prohibits the "misbranding" of a prescription drug. Under 21 U.S.C. [sections] 352(n), a prescription drug is considered "misbranded" unless the manufacturer, packer or distributor provides a "true statement," which must include (1) the product's scientific ("established") name, "printed prominently and in type at least half as large as that used for any trade name or brand name thereof"; (2) the product's formula "showing quantitatively each ingredient of such drug" consistent with the product's label; and (3) "brief summary relating to side effects, contraindications, and effectiveness." The "true statement" must appear in "all advertisements and other descriptive matter issued or caused to be issued by the manufacturer."

   The FDCA requires manufacturers who advertise pharmaceutical and biological products for humans and animals to provide information regarding the product's uses and risks. Advertisements for prescription drugs and biologicals must contain "information in brief summary relating to side effects, contraindications, and effectiveness." This requirement, referred to as the "brief summary," is explained in the regulations and in FDA guidance documents.

2. Regulations

   1. General

      While the FDCA is unclear as to what constitutes "advertising," the regulations clearly distinguish between "labeling" and "advertising." Labeling, subject to strict and extensive regulation, is addressed in 21 C.F.R. [sections] 201 and is beyond the scope of this article. Advertising is covered by 21 C.F.R. [sections] 202.1, which is the primary regulation directed at pharmaceutical product advertising.

      Section 202.1(1)(1) states that it applies to all advertisements for prescription drugs, including "advertisements in published journals, magazines, other periodicals, and newspapers, and other advertisements broadcast through media such as radio, television, and telephone communication systems." In contrast, Section 202.1(1)(2) provides a list of items (from brochures to references to calendars) "for use by medical practitioners, pharmacists, or nurses, containing drug information" from the manufacturer or distributor which constitute "labeling."

      Although applicable to all types of advertising, regardless of media, a close reading of Section 202.1 reveals that it is geared primarily toward print advertising. However, the publication FDA Guidance for Industry: Consumer-Directed Broadcast Advertisements, discussed later in this article, offers suggestions for compliance with Section 202.1 in broadcast advertisements. In any event, thorough familiarity with Section 202.1 is necessary for giving advice as to any type of prescription drug advertising.

      Section 202.1 establishes numerous requirements for prescription drug advertisements, with the "brief summary" requirement being the most significant.

   2. Side Effects and Contraindications: Brief Summary

      Essentially, Section 202.1(e)(1) states that the brief summary is "a true statement of information ... relating to side effects, contraindications, and effectiveness." Lest there be any mistake, the regulation specifies that the terms "side effects" and "contraindications" include warnings, precautions, cautions, "special considerations" and "important notes."

      Each specific side effect, contraindication, warning, caution, precaution, special consideration and "important note" that appears in the product's labeling must be listed in the advertisement. Less than all side effects may be listed if the advertisement promotes only a particular purpose of the drug, but only to the extent such limitations have previously been approved in the product labeling. Similarly, a...